Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Newly diagnosed with wet AMD within 9 months of screening visit
Participant must have received at least 2 prior ITV anti-vascular endothelial growth factor (VEGF) injections. However, the most recent anti-VEGF injection must have been ranibizumab and must have occurred at least 7 days prior to the screening visit
Demonstrated response to prior ITV anti-VEGF treatment
Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts of 20/20-20/200 Snellen equivalent
You may not be if
Treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye
Study eye treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit
History of laser photocoagulation, Visudyne®, ITV corticosteroid injection, vitrectomy surgery, submacular surgery, device implantation, or other surgical intervention for AMD in the study eye
Prior participation in a clinical trial involving anti-angiogenic drugs, other than ranibizumab, in either eye within 2 months of the randomization visit
Subretinal hemorrhage in the study eye that involves the center of the fovea
Subfoveal fibrosis, or atrophy in the study eye
Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
Uncontrolled ocular hypertension or glaucoma in the study eye
History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye
Uncontrolled blood pressure
Uncontrolled atrial fibrillation within 3 months of informed consent
History of myocardial infarction or stroke within the last 3 months prior to informed consent
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant, that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications
Use of oral corticosteroids
Current treatment for any active systemic infection
Use of anticoagulants, anti-platelets (other than aspirin), or medications known to exert similar effects
Active malignancy within 12 months of randomization
History of allergy to fluorescein
Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)
Clareo Health | Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
